ICU Medical, Inc. has recalled LifeShield Drug Library Management (DLM) software, specifically versions 2.1 and 2.2 of the LifeShield Infusion Safety Software Suite. This recall affects 12 units distributed within the United States and involves defects where the software may fail to enforce certain dosing limits or allow unauthorized users to modify drug library settings. No injuries or incidents have been reported, but ICU Medical is initiating this voluntary recall to address these software management issues.
The software defects may cause the system to ignore specific dosing limits or allow unauthorized users to approve incorrect library parameters. This could lead to the over-delivery of medication or the use of incorrect therapy parameters, potentially causing serious health complications or overdose.
Recall Number: Z-1763-2025; Quantity distributed: 12 US, 3 OUS.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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